Comparison Between OSS and 2L PEG/Asc for Bowel Preparation of Elderly People

NCT ID: NCT03520361

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-02

Study Completion Date

2019-06-30

Brief Summary

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For evaluation of the usefulness of oral sulfate solution (OSS) for bowel preparation of elderly people, investigators compare the efficacy, tolerability and safety between OSS and 2L polyethylene glycol (PEG) with ascorbic acid (Asc).

Detailed Description

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This study is a multicenter, prospective, randomized parallel arm, investigator initiated trial.

The aim of study is to compare oral sulfate solution (OSS) with 2L polyethylene glycol (PEG) with ascorbic acid (Asc) for bowel preparation in elderly people.

99 participants will be enrolled in each group (198 in total). The primary outcome is the efficacy of bowel preparation. Secondary outcomes are tolerability, satisfaction, and safety.

Conditions

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Colonoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators
Single Blind (Investigator)

Study Groups

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Oral sulfate solution (OSS) taking group

On the evening before colonoscopy, drink 177ml of OSS (Suclear®) (473ml including water in container), additionally allow another 946 ml of water. On the day of colonoscopy, drink 177ml of OSS (473ml including water in container), additionally allow another 946 ml of water.

Group Type EXPERIMENTAL

Oral sulfate solution (OSS)

Intervention Type DRUG

Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g

2L PEG/Asc taking group

On the evening before colonoscopy, drink 1L of 2L PEG/Asc (Haprep®) solution, additionally allow another 500 ml of water. On the day of colonoscopy, drink 1L of 2L PEG/Asc solution, additionally allow another 500 ml of water.

Group Type ACTIVE_COMPARATOR

2L PEG/Asc

Intervention Type DRUG

Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g

Interventions

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Oral sulfate solution (OSS)

Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g

Intervention Type DRUG

2L PEG/Asc

Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g

Intervention Type DRUG

Other Intervention Names

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Suclear® solution (Phambio Korea, Seoul, Korea) Haprep® powder (Phambio Korea, Seoul, Korea)

Eligibility Criteria

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Inclusion Criteria

* Colonoscopy examinee aged 65-80
* Examinee agree with informed consent

Exclusion Criteria

* Cognitive disorder, mental retardation
* Bowel obstruction
* Severe constipation (\<3 bowel movements per week with or without regular or intermittent laxatives)
* History of bowel surgery
* Liver cirrhosis or ascites
* Heart failure, cardiac disease (ischemic heart disease or coronary artery disease within the last 6 months)
* Inflammatory bowel disease
* Pregnancy, lactating woman
* Renal impairment or history of impaired renal function
* History of hypersensitivity reaction to bowel preparation
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KangWon National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sung Chul Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KangWon National University Hospital

Locations

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Kangwon National University Hospital

Chuncheon, Gangwon-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2017-03-011

Identifier Type: -

Identifier Source: org_study_id

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